MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-11-10 for CONTROLLER, VEST 105 P105CM manufactured by Hill-rom Singapore.
[91802352]
The patient saw her doctor for rib pain and had an x-ray on (b)(6) 2017. The patient had another x-ray on (b)(6) 2017 and was diagnosed with broken ribs. The patient is returning the device. The account made no allegation of the vest malfunctioning. Based on this information, no further action is required. This is a serious injury per fda definition.
Patient Sequence No: 1, Text Type: N, H10
[91802353]
Hill-rom received a report from the account stating the vest broke the patient's ribs. The device was located at the account. There was a patient/user injury reported. This report was filed in our complaint handling system as complaint # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008145987-2017-00003 |
| MDR Report Key | 7020246 |
| Report Source | CONSUMER |
| Date Received | 2017-11-10 |
| Date of Report | 2017-11-02 |
| Date of Event | 2017-05-22 |
| Date Mfgr Received | 2017-11-02 |
| Device Manufacturer Date | 2017-04-21 |
| Date Added to Maude | 2017-11-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ERIN PADGETT |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129312791 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTROLLER, VEST 105 |
| Generic Name | THE VEST |
| Product Code | BYI |
| Date Received | 2017-11-10 |
| Model Number | P105CM |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM SINGAPORE |
| Manufacturer Address | 1 YISHUN AVENUE 7 SINGAPORE, NORTH EAST 768923 SN 768923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-10 |